Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients: Final 2-Year Results From Onyx ONE

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Biomaterials Science

Background:

• High-bleeding-risk (HBR) patients require careful antiplatelet therapy management after percutaneous coronary intervention.
• Comparing polymer-based zotarolimus-eluting stents (ZES) with polymer-free biolimus A9-coated stents (DCS) is crucial for optimizing treatment strategies.

Purpose of the Study:

• To report the final 2-year outcomes of the Onyx ONE trial, comparing Resolute Onyx ZES with BioFreedom DCS.
• To evaluate the safety and effectiveness of a 1-month dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) regimen in HBR patients.

Main Methods:

• The Onyx ONE randomized controlled trial enrolled HBR patients assigned to ZES or DCS.
• Patients received 1-month DAPT, followed by SAPT if event-free.
• Primary safety and secondary effectiveness endpoints were assessed at 1 and 2 years.

Main Results:

• A total of 1,003 patients received ZES and 993 received DCS, with high follow-up rates at 2 years.
• The primary safety endpoint occurred in 21.2% of ZES patients and 20.7% of DCS patients (P=0.78).
• The secondary effectiveness endpoint occurred in 22.1% of ZES patients and 21.0% of DCS patients (P=0.54).

Conclusions:

• Resolute Onyx ZES demonstrated similar 2-year safety and effectiveness compared to BioFreedom DCS in HBR patients on a 1-month DAPT regimen.
• These findings support the use of both stent types in HBR patients undergoing short-term DAPT.